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JKPGA urges FSSAI action against marketing of high-strength therapeutic formulations as food
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Peethambaran Kunnathoor, Chennai
July 17 , 2026
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In a major development concerning public health and drug regulatory integrity, the Jammu and Kashmir Pharmacy Graduates’ Association (JKPGA) has formally approached the Food Safety and Standards Authority of India (FSSAI) to address the rampant marketing of high-strength therapeutic formulations as 'Food for Special Medical Purpose (FSMP)'.
The association has voiced serious concerns over the growing trend of labelling highly potent medicinal products under food categories, a practice it states explicitly circumvents the legal boundaries meant to separate food items from pharmaceuticals.
In a detailed representation addressed to the FSSAI chairperson, Punya Salila Srivastava, the association general secretary Rafi Malik highlighted that several products currently in the market contain active ingredients that vastly exceed the Recommended Dietary Allowances (RDA) set by the Indian Council of Medical Research (ICMR), 2020. The JKPGA underscored that these products exhibit a clear therapeutic intent aimed at treating or mitigating specific diseases, rather than serving routine nutritional purposes. By slipping into the market under the guise of food, these formulations raise critical regulatory alarms.
Chief among the flagged formulations are high-dose cholecalciferol (vitamin D3) preparations. The association pointed out that products containing up to 60,000 IU of vitamin D3 are routinely being labelled as 'Food for Medicinal Use', despite delivering an astonishing 100 times the ICMR-recommended daily intake of 600 IU. Even preparations with 800 IU surpass the threshold. The JKPGA maintains that such strengths constitute clear pharmacological therapies designed for deficiency correction rather than simple dietary supplementation.
Similarly, the representation draws urgent attention to thiamine hydrochloride oral drops manufactured at a strength of 50 mg/mL. Delivering approximately 25 to 40 times the daily allowance mandated by the ICMR (1.2–2 mg/day), these drops are unmistakably therapeutic in nature. The pharmacists body argues that treating such high-concentration vitamin formulations as regular food articles severely distorts the legislative frameworks laid out in both the Food Safety and Standards Act, 2006 and the Drugs and Cosmetics Act, 1940.
The JKPGA also spotlighted the unauthorized inclusion of heme iron polypeptide (HIP) preparations within the food sector. Extensively prescribed by clinicians for the treatment of iron deficiency anaemia, these high-intent medical formulations are increasingly being commercialized as food. The representation emphasizes that this directly violates current national food safety guidelines, which strictly regulate and restrict the use of heme iron in any article of food.
To restore regulatory order, the JKPGA has put forth a series of firm demands to the apex food authority. The association has urged the FSSAI to execute a comprehensive review of all products categorized as FSMP that carry pharmacological quantities of vitamins, minerals, and amino acids. Further, they have demanded that competent enforcement authorities thoroughly investigate the statutory compliance of the flagged vitamin D3, thiamine, and heme iron products to initiate immediate legal action against verified violators.
Concluding its plea, the association general secretary Rafi Malik called upon the FSSAI to issue clear, unambiguous regulatory guidance to manufacturers, marketers, and licensing officers to ensure that products meant for preventing or treating diseases remain under the correct pharmaceutical legal framework. According to him, timely intervention is vital to safeguard patient safety, maintain rational prescribing practices, protect consumers, and ensure a fair and transparent competitive landscape across the pharmaceutical and food sectors.
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